A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China.
OBJECTIVE
To evaluate the safety and efficacy of combining artemether (AM) and praziquantel (PZQ) in different regimens for treating acute schistosomiasis japonica.


METHODS
We undertook a randomized, double-blind, placebo-controlled trial within four specialized schistosomiasis hospitals in the Dongting Lake region, Hunan province, China, between May 2003 and December 2005. Study participants were randomized into one of four treatment regimes: group A received 60 mg/kg PZQ + 6 mg/kg AM; group B received 60 mg/kg PZQ + AM placebo; group C received 120 mg/kg PZQ + 6 mg/kg AM; and group D received 120 mg/kg PZQ + AM placebo. All participants were followed up over a 45-day period. The primary endpoint of the trial was human infection status (determined by positive stool examination). Secondary endpoints involved clinical observations and blood biochemistry, including monitoring haemoglobin and alanine aminotransferase levels over time.


RESULTS
Treatment efficacies of the four different treatment regimens were 98.0%, 96.4%, 97.7% and 95.7% for group A, B, C, and D respectively (P > 0.05). The group B had a greater treatment efficacy (96.4%) than the group D (95.7%) (P > 0.05). Group A treatment was better for clearance of fever (P < 0.05) and resulted in a shorter hospitalization time (P < 0.05).


CONCLUSIONS
This is the first report of a randomized, double-blind, placebo-controlled trial for evaluating combined chemotherapy with AM and two different dosages (60 mg/kg and 120 mg/kg) of PZQ in the treatment of acute schistosomiasis japonica in China. The combination of AM and PZQ chemotherapy did not improve treatment efficacy compared with PZQ alone. PZQ given as a dosage of 60 mg/kg (1 day, 3 x 20 mg/kg doses at 4-5 hour intervals) may be as effective as a dosage of 120 mg/kg (6 days, 20 mg/kg for each day split into 3 doses at 4-5 hour intervals).
Hou
Xun-Ya
XY
Hunan Institute of Parasitic Diseases, WHO Collaborating Centre for Research and Control on Schistosomiasis in Lake Region, Yueyang, China.
McManus
Donald P
DP
Gray
Darren J
DJ
Balen
Julie
J
Luo
Xin-Song
XS
He
Yong-Kang
YK
Ellis
Magda
M
Williams
Gail M
GM
Li
Yue-Sheng
YS
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000871:Anthelmintics / Q000627:therapeutic use*; D000077549:Artemether; D037621:Artemisinins / Q000627:therapeutic use*; D002648:Child; D002681:China; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D011223:Praziquantel / Q000627:therapeutic use*; D012554:Schistosomiasis japonica / Q000175:diagnosis / Q000188:drug therapy*; D012556:Schistosomicides / Q000627:therapeutic use*; D055815:Young Adult
D000871:Anthelmintics; D037621:Artemisinins; D012556:Schistosomicides; D011223:Praziquantel; D000077549:Artemether